Drug Information for Trandate (Prometheus Laboratories Inc.): ADVERSE REACTIONS

  • TRANDATE Injection is usually well tolerated. Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require labetalol HCl withdrawal. Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving TRANDATE Injection. Moderate hypotension occurred in 1 of 100 patients while supine. Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients.

    The following also were reported with TRANDATE Injection with the incidence per 100 patients as noted:

    Cardiovascular System: Ventricular arrhythmia in 1.

    Central and Peripheral Nervous Systems: Dizziness in 9, tingling of the scalp/skin in 7, hypoesthesia (numbness) and vertigo in 1 each.

    Gastrointestinal System: Nausea in 13, vomiting in 4, dyspepsia and taste distortion in 1 each.

    Metabolic Disorders: Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8 of 100 patients; these were associated with drops in blood pressure, generally in patients with prior renal insufficiency.

    Psychiatric Disorders: Somnolence/yawning in 3.

    Respiratory System: Wheezing in 1.

    Skin: Pruritus in 1.

    The incidence of adverse reactions depends upon the dose of labetalol HCl. The largest experience is with oral labetalol HCl (see TRANDATE® [labetalol hydrochloride] Tablets Product Information for details). Certain of the side effects increased with increasing oral dose, as shown in the following table that depicts the entire US therapeutic trials data base for adverse reactions that are clearly or possibly dose related.

    Labetalol HCI
    Daily Dose (mg)200300400600800900120016002400
    Number of patients522181606608503117411242175
    Dizziness (%)23335191316
    Nasal stuffiness112222456
    Ejaculation failure021230435

    In addition, a number of other less common adverse events have been reported:

    Cardiovascular: Hypotension, and rarely, syncope, bradycardia, heart block.

    Liver and Biliary System: Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.

    Hypersensitivity: Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions.

    The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl during investigational use and extensive foreign marketing experience.

  • Clinical Laboratory Tests: Among patients dosed with TRANDATE Tablets, there have been reversible increases of serum transaminases in 4% of patients tested and, more rarely, reversible increases in blood urea.

  • Drug Information Provided by National Library of Medicine (NLM).